In the accuracy management of an automatic analyzer for clinical inspection, an accuracy management material (control sample), the concentration of which is know, is interruptedly measured during intervals between measurements of patient samples, and whether or not measurement results deviate from a control value associated with the accuracy management material is checked, or circadian variation and day to day variation are checked. Thus, the precision of the automatic analyzer is assessed by the precision of the measurement results. In addition, presence or absence of abnormality in the automatic analyzer, judgment on deterioration of a reagent, preparation quality of standard solution or the like is detected by measurement results of the accuracy management material, and calibration results. These series of accuracy management are executed by a clinical laboratory technologist who summarizes the calibration results and the measurement results of the accuracy management material and records and stores the summarized data. Examples are shown as below.
At present, a plurality of accuracy management materials have already been developed, and are on the market, and management of the accuracy management materials is performed not only by clinical laboratory technologists of clinical laboratories, but also by public institutions.
(1) A clinical laboratory uses an accuracy management material sold by a reagent manufacturer on the market, inputs a concentration value and a standard deviation, which are associated with the accuracy management material, into a data management computer in a hospital as control values, and manages measurement results of the accuracy management material.(2) A clinical laboratory uses an accuracy management material sold by a reagent manufacturer on the market, and transmits measurement result data of the accuracy management material of the clinical laboratory to the reagent manufacturer through a network line, by mail or the like. The reagent manufacturer then summarizes the data. The summarized measurement results of the accuracy management material are subjected to statistical processing, and are then sent to each hospital.(3) An organization such as the Japan Medical Association distributes nationwide common control samples to hospitals, clinical laboratory inspection centers and the like all over the country all at once about once or twice a year to request them to perform measurement. The organization summarizes the measurement results, and then subjects the summarized measurement results to statistical processing. Besides the Japan Medical Association, the management is carried out on a prefecture basis, on a hospital group basis or the like.(4) Manufacturers of automatic analyzers put, to practical use, systems in which automatic analyzers as own products, which have been sold and installed in clinical laboratories of hospitals and inspection centers, are connected to a service server through network lines to enable remote monitoring of the automatic analyzers.
Patent document 1 discloses the related art of the example (4). A clinical laboratory of each hospital transmits calibration results, and measurement results of an accuracy management material, which are associated with a reagent lot number, a calibrator lot number and a lot number of the accuracy management material at the time of measurement, to a support center in real time through a network line. The support center summarizes the calibration results and data of the accuracy management material, and then subjects the summarized data to statistical processing to check a change from the preceding day, and to check a deviation from a reference value. The clinical laboratory of each hospital makes an access to the support center through the network line to check a situation of the accuracy management of the automatic analyzer.